Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Registration Number
- NCT01569295
- Lead Sponsor
- Gilead Sciences
- Brief Summary
The primary objective of this study is to evaluate the effect of the addition of idelalisib (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in participants with previously treated chronic lymphocytic leukemia (CLL)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- Previously treated recurrent CLL
- Measurable lymphadenopathy
- Requires therapy for CLL
- Has experienced CLL progression < 36 months since the completion of the last prior therapy
Key
- Recent history of a major non-CLL malignancy
- Evidence of an ongoing infection
- CLL refractory to bendamustine
- Concurrent participation in another therapeutic clinical trial
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Idelalisib+bendamustine+rituximab Rituximab Participants will receive idelalisib plus bendamustine and rituximab Idelalisib+bendamustine+rituximab Idelalisib Participants will receive idelalisib plus bendamustine and rituximab Idelalisib+bendamustine+rituximab Bendamustine Participants will receive idelalisib plus bendamustine and rituximab Placebo to match idelalisib+bendamustine+rituximab Rituximab Participants will receive placebo to match idelalisib plus bendamustine and rituximab Placebo to match idelalisib+bendamustine+rituximab Bendamustine Participants will receive placebo to match idelalisib plus bendamustine and rituximab Placebo to match idelalisib+bendamustine+rituximab Placebo to match idelalisib Participants will receive placebo to match idelalisib plus bendamustine and rituximab
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Up to 84 months PFS was defined as the interval from randomization to the earlier of the first documentation of definitive disease progression or death from any cause. PFS (months) = (minimum (date of disease progression, date of death) - date of randomization + 1)/30.4375.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 84 months ORR was the percentage of participants who achieved a complete response (CR), CR with incomplete marrow recovery (CRi,) or partial response (PR) and maintained the response for at least 12 weeks. CR was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy.
PR was defined as \>1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, \> 100000/μL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors. CRi was defined as all criteria for CR met but with persistent anemia, thrombocytopenia, neutropenia or a hypocellular bone marrow.Lymph Node Response Rate Up to 84 months Lymph node response rate was defined as the percentage of participants who achieved a ≥ 50% decrease from baseline in the sum of the products of the greatest perpendicular diameters (SPD) of index lesions.
Overall Survival Up to 84 months Overall survival (OS) was defined as the interval from randomization to death from any cause. Overall survival (months) = (date of death - date of randomization + 1)/30.4375.
Complete Response Rate Up to 84 months Complete response (CR) rate was defined as the percentage of participants who achieved a CR.
Trial Locations
- Locations (104)
University of Florida
🇺🇸Gainesville, Florida, United States
University College London
🇬🇧London, United Kingdom
G. Genimatas Hospital
🇬🇷Athens, Greece
Centre Hospitalier Lyon Sud
🇫🇷Pierre Bénite, France
Cancer Care Northwest, US Oncology
🇺🇸Spokane, Washington, United States
Texas Oncology
🇺🇸Fort Worth, Texas, United States
Fakultní nemocnice Hradec Králové
🇨🇿Hradec Králové, Czechia
Centre Jean Bernard - Clinique Victor Hugo
🇫🇷Le Mans cedex, France
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
🇵🇱Lodz, Poland
Klinichki Bolnicki Centar-Zagreb
🇭🇷Zagreb, Croatia
UZ Leuven
🇧🇪Leuven, Belgium
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Tallian Gyula utca 20-32
🇭🇺Kaposvár, Hungary
University Hospital Merkur
🇭🇷Zagreb, Croatia
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
🇧🇪Antwerpen, Belgium
UZ Gent
🇧🇪Gent, Belgium
University General Hospital of Patras
🇬🇷Patras, Greece
Charleston Hematology Oncology
🇺🇸Charleston, South Carolina, United States
Hôpitaux de Brabois
🇫🇷Vandoeuvre-lés-Nancy, France
Stanford Cancer Center
🇺🇸Palo Alto, California, United States
Summit Medical Group, P.A.
🇺🇸Morristown, New Jersey, United States
Saratov State Medical University
🇷🇺Saratov, Russian Federation
Ryazan Regional Clinical Hospital
🇷🇺Ryazan, Russian Federation
State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1
🇷🇺Volgograd, Russian Federation
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Cataluña, Spain
King's College Hospital
🇬🇧London, United Kingdom
Russian Oncology Research Center (N.N. Blokhin)
🇷🇺Moscow, Russian Federation
Novosibirsk State Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Hospital Clinic de Barcelona
🇪🇸Barcelona, Cataluña, Spain
St. James University Hospital
🇬🇧Leeds, United Kingdom
Ondokuz Mayis University Faculty of Medicine
🇹🇷Samsun, Turkey
St Bartholomews Hospital
🇬🇧London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Hospital 12 de Octubre
🇪🇸Madrid, Madrid, Communidad De, Spain
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Gazi University Medical Faculty Gazi Hospital
🇹🇷Ankara, Turkey
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, United Kingdom
Winship Cancer Institute at Emory University
🇺🇸Atlanta, Georgia, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Texas Oncology PA
🇺🇸Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
Ankara University Medical Faculty
🇹🇷Ankara, Turkey
Hammersmith Hospital
🇬🇧London, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
CHRU Lille-Hôpital Claude Huriez
🇫🇷Lille, France
Centre Hospitalier de Mulhouse
🇫🇷Mulhouse, France
Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Országos Onkológiai Intézet
🇭🇺Budapest, Hungary
Mater Misericordiae Hospital
🇮🇪Dublin, Ireland
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
🇭🇺Debrecen, Hungary
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Ospedale Oncologico Regionale A. Businco
🇮🇹Cagliari, Italy
Azienda Ospedaliera Universitaria San Giovanni Battista-Molinette
🇮🇹Torino, Italy
Malopolskie Centrum Medyczne
🇵🇱Krakow, Poland
Szpital Specjalistyczny w Brzozowie
🇵🇱Brzozow, Poland
Wojewodzki Szpital w Opolu
🇵🇱Opole, Poland
"Colentina" Clinical Hospital
🇷🇴Bucharest, Romania
Hospital Santa Maria
🇵🇹Lisboa, Portugal
Research Institute of Hematology and Blood Transfusion
🇷🇺St. Petersburg, Russian Federation
"Fundeni" Clinical Institute
🇷🇴Bucharest, Romania
Nizhegorodskaya Regional Clinical Hospital n.a. N.A. Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
Hospital Universitario Germans Trias i Pujol
🇪🇸Badalona, Cataluña, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Majadahonda, Madrid, Communidad De, Spain
Istanbul University Istanbul Medical Faculty
🇹🇷Istanbul, Turkey
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Birmingham Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
St Vincent's Hospital - Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Fakultni nemocnice Brno
🇨🇿Brno, Czechia
Cancer Care Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Virginia Cancer Specialists, PC
🇺🇸Vancouver, Washington, United States
Gosford Hospital
🇦🇺Gosford, New South Wales, Australia
Centre Léon Bérard - Centre régional de lutte contre le cancer Rhône-Alpes
🇫🇷Lyon, France
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
Hopital Henri Mondor
🇫🇷Créteil, France
CHU Hôtel-Dieu-Service Hématologie
🇫🇷Nantes, France
Churchill Hospital
🇬🇧Oxford, United Kingdom
Hopital Purpan
🇫🇷Toulouse, France
Emergency County Clinical Hospital Brasov
🇷🇴Brasov, Romania
Samodzielny Publiczny Szpital Kliniczny Nr 1
🇵🇱Lublin, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
🇵🇱Warszawa, Poland
"Instituto Portugues de Oncologia do Porto Francisco Gentil (IPOPFG, EPE)
🇵🇹Porto, Portugal
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
🇭🇺Szeged, Hungary
Centralny Szpital Kliniczny MSW w Warszawie
🇵🇱Warszawa, Poland
Regional Oncology Institute Iasi
🇷🇴Iasi, Romania
Clinical Hospital "Dubrava"
🇭🇷Zagreb, Croatia
Monash Medical Centre - Clayton Campus
🇦🇺Clayton, Victoria, Australia
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom